The safety of medicines and environmental chemical exposures during pregnancy remains a major challenge in healthcare and regulatory science. Pregnant women are rarely included in clinical trials, and current risk assessment approaches rely heavily on animal testing or limited human data. As a result, there is significant uncertainty in understanding how pharmaceuticals and environmental pollutants affect the developing fetus, contributing to serious public health concerns such as preterm birth, neonatal mortality, and long-term health complications.
LIFESAVER addressed this challenge by developing a new scientific and technological framework to improve the assessment of risks to maternal and fetal health. The project aimed to generate robust, human-relevant data and tools to support more reliable and evidence-based regulatory decision-making, in line with European priorities on zero pollution, reduced animal testing, and safer medicines.
To achieve this, LIFESAVER developed an integrated biodigital approach combining advanced in vitro and in silico methods. This included bioengineered models of the placental interface, innovative bioprinting technologies, biosensing systems, and computational models to predict substance transfer and toxicity. These components were brought together into a functional biodigital twin prototype supported by validated cell models, scalable membrane technologies, and a microphysiological system platform.
The project also generated new experimental datasets, validated testing methodologies, and contributed to the development of New Approach Methodologies for maternal–fetal risk assessment. In parallel, LIFESAVER developed a policy toolbox and engaged with regulatory and industry stakeholders to support the integration of these approaches into future regulatory frameworks.
Conclusions of the action:
LIFESAVER successfully demonstrated the feasibility of a biodigital platform for assessing drug and chemical safety during pregnancy. The project delivered validated tools, datasets, and a functional prototype that together provide a stronger scientific basis for evaluating maternal–fetal exposure.
The results show that combining in vitro and in silico approaches can significantly improve the prediction of fetal exposure and risk, enabling safer use of medicines and better protection of unborn children. This approach supports the transition away from animal testing and contributes to the development of regulatory endpoints for future risk assessment frameworks.
LIFESAVER also established a clear pathway for further development and uptake, including engagement with pharmaceutical stakeholders as early adopters and the definition of a post-project exploitation strategy.
Overall, the project has delivered a significant step forward in enabling more reliable, ethical, and data-driven approaches to maternal and fetal health assessment. It contributes to European policy objectives under the Green Deal, the Zero Pollution Action Plan, the Chemicals Strategy for Sustainability, and the Pharmaceutical Strategy for Europe, while supporting innovation and safer healthcare for pregnant women and their children.
